BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM

    MDR report key: 3242879 · Received July 19, 2013

    Report

    Report Number
    3001743903-2013-00037
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED FOR F/U WITH DYSPNEA ON EXERTION AND A TEE REVEALED FLAIL LEAFLET WITH 4+ MITRAL REGURGITATION. A RE-DO MVR WAS PERFORMED WHERE A 29 MM SJM EPIC VALVE WAS IMPLANTED. THE PHYSICIAN NOTED THAT ONE LEAFLET OF THE EXPLANTED VALVE HAD TWO PERFORATIONS NEAR THE SEWING RING. THE PT WAS REPORTED TO BE IN STABLE CONDITION POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338048 SJM BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM STENTED TISSUE VALVE LWR ST JUDE MEDICAL B100-29M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R